ClinicalTrials.gov
ClinicalTrials.gov Menu

REducing Anxiety in CHildren Undergoing Procedures (REACH-UP!)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03054077
Recruitment Status : Completed
First Posted : February 15, 2017
Results First Posted : October 10, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition Ambulatory Surgery
Intervention Other: iPad with downloaded games
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control or Group 1 Intervention Group or Group 2
Hide Arm/Group Description This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.

This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.

iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit

Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Control or Group 1 Intervention Group or Group 2 Total
Hide Arm/Group Description This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.

This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.

iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
12
 100.0%
12
 100.0%
24
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
4
  33.3%
3
  25.0%
7
  29.2%
Male
8
  66.7%
9
  75.0%
17
  70.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
 100.0%
12
 100.0%
24
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   8.3%
1
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  58.3%
4
  33.3%
11
  45.8%
White
4
  33.3%
7
  58.3%
11
  45.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   8.3%
0
   0.0%
1
   4.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2
Hide Description

The Modified Yale Preoperative Anxiety Scale- Short form (mYPAS-SF) Ratings produce 4 mYPAS scores (1 for each time point)

Areas scored:

Activity (1,2,3, or 4) Vocalizations (1,2,3,4,5,or 6) Emotional Expressivity (1,2,3, or 4) State of Apparent arousal (1,2,3, or 4) Scoring: Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the “vocalizations” item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100.

This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.

Comparison of scores between Group 1 and Group 2 to see if changes in anxiety scores occurred with the addition of the iPad.

All data will be gathered with review at the close of the study which is anticipated to occur in 5/20/2017.

Time Frame Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants for whom 3 time points were collected at Baseline T1, T2, and T3
Arm/Group Title Control or Group 1 Intervention Group or Group 2
Hide Arm/Group Description:
This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.

This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.

iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit

Overall Number of Participants Analyzed 11 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Time Point 1
25
(19.81 to 30.15)
29.69
(18.73 to 40.65)
Time Point 2
28.82
(19.55 to 38.09)
24.83
(21.23 to 28.43)
Time Point 3
34.09
(13.19 to 54.99)
26.56
(15.75 to 37.37)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control or Group 1 Intervention Group or Group 2
Hide Arm/Group Description This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.

This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.

iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit

All-Cause Mortality
Control or Group 1 Intervention Group or Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control or Group 1 Intervention Group or Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control or Group 1 Intervention Group or Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Debra Shockey
Organization: Virginia Commonwealth University
Phone: 804-828-3744
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03054077     History of Changes
Other Study ID Numbers: HM200008056
First Submitted: January 31, 2017
First Posted: February 15, 2017
Results First Submitted: July 7, 2017
Results First Posted: October 10, 2017
Last Update Posted: October 10, 2017